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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM
Classification Namecatheter, coronary, atherectomy
Generic Nameptca 03/16/92=final gmp approval request
ApplicantDEVICES FOR VASCULAR INTERVENTION, INC.
PMA NumberP890043
Supplement NumberS015
Date Received12/06/1991
Decision Date12/07/1992
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
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